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The Celerity™ HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow or lighter, when the device has been exposed to the:

• · Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• · Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

The Celerity™ HP Multivariable Chemical Indicator is a vaporized hydrogen peroxide multivariable chemical indicator. It is designed for routine monitoring of the following cycles:

• Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty sterilization ● cycle of a V-PRO Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD ● System, including those systems with ALLClear Technology.

The VERIFY® HPU Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units when placed within packs to be sterilized to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen, Flexible, Fast Non Lumen, or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System.

The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.
The tape may be used in the following sterilization cycles:

• . Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX, maX 2, 60, and s2 Low Temperature Sterilization Systems.
• STERRAD® 100S Sterilizer (Default Cycle)
• . Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear
• Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX . Sterilizer without ALLClear.

The Celerity "M HP Chemical Indicator is an ISO 11140-1:2014 Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units through a visible change from magenta to orange/vellow or lighter. when the device has been exposed. No changes have been made to the device other than additional testing and updating the labeling for the Specialty Cycle.

The Celerity™ HP Multivariable Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. If the critical variables are achieved, the color of the indicator ink changes from magenta to orange/yellow or lighter yellow when exposed to the V-PRO® Low Temperature Sterilization System cycles or ASP STERRAD® System cycles. The indicator is validated to function as a multiple variable indicator with increased resistance characteristics similar to ISO 11140-1:2014 end points for a Type 4 Vaporized Hydrogen Peroxide (VHP) Chemical Indicator (CI). No changes have been made to the device other than additional testing and updating the labeling for Specialty cycle.

The VERIFY HPU Chemical Indicator (Chemical Indicator) is a Type 1 process indicator in accordance with ANSI/AAMI/ISO 11140-1:2014. The indicators are used in the processing cycles to indicate exposure to the following sterilization cycles in the V-PRO Low Temperature Sterilization Systems. The indicator ink spot on the proposed Chemical Indicator undergoes a color change from magenta to vellow when exposed to the defined processing conditions.

The VERIFY VH2O2 Indicator Tape (Indicator Tape) is a 3/" wide crepe paper tape printed with diagonal stripes of a vaporized hydrogen peroxide (VHP) reactive ink. The ink is sealed with a varnish, the function of which is to inhibit removal of the ink via transference or by the adhesive (as the tape is dispensed). The reactive ink meets the performance specifications for a Type 1 process indicator for vaporized hydrogen peroxide as defined in ANSI/AAMI/ISO 11140-1:2014.

The provided text describes premarket notification (510(k)) submissions for four chemical indicators (CIs) used in sterilization processes:

1. Celerity™ HP Chemical Indicator (CI) (K231488) on pages 3-5.
2. Celerity™ HP Multivariable Chemical Indicator (CI) (K231488) on pages 6-9.
3. VERIFY HPU Chemical Indicator (CI) (K231488) on pages 10-12.
4. VERIFY VH2O2 Indicator Tape (K231488) on pages 13-16.

For each of these devices, the core purpose of the 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, primarily by showing that the indicators function as intended even with an expanded "Indications for Use" to include the "Specialty" sterilization cycle of the V-PRO® Low Temperature Sterilization System.

The information provided does not pertain to a medical device that uses AI or machine learning, nor does it involve human readers/experts interpreting medical images. Instead, it describes performance testing of chemical indicators, which are physical objects designed to change color under specific sterilization conditions. Therefore, the requested information elements such as "Number of experts used to establish ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Effect size of human readers improvement with AI," "Stand-alone algorithm performance," "Training set sample size," and "How ground truth for training set was established" are not applicable to this type of device and study.

The acceptance criteria and reported performance for each device are derived from "Simulated Use Testing" and are consistently focused on the physical color change and the indicator's integrity.

Here's a summary of the relevant information provided for each product:

1. Celerity™ HP Chemical Indicator (CI) (K231488)

Acceptance Criteria and Reported Device Performance:

Study that proves the device meets the acceptance criteria:

• Sample Size: Not explicitly stated, but the context implies a sufficient number of indicators were tested to demonstrate consistent performance.
• Data Provenance: Not explicitly stated, but the manufacturing facility is in the United Kingdom, and the testing simulates "typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle." This suggests laboratory-based, prospective testing designed to validate performance under specified conditions.
• Type of Ground Truth: The ground truth is the physical observation of the color change of the chemical indicator after exposure to the V-PRO maX 2 Sterilizer Specialty cycle, indicating that the sterilization conditions were met. This is a direct physical outcome.

2. Celerity™ HP Multivariable Chemical Indicator (CI) (K231488)

Acceptance Criteria and Reported Device Performance:

Study that proves the device meets the acceptance criteria:

• Sample Size: Not explicitly stated.
• Data Provenance: Not explicitly stated, but similar to the previous Celerity CI, implies laboratory-based, prospective testing.
• Type of Ground Truth: The ground truth is the physical observation of the color change of the chemical indicator after exposure to the V-PRO maX 2 Sterilizer Specialty cycle, confirming proper function as a multivariable indicator.

3. VERIFY HPU Chemical Indicator (CI) (K231488)

Acceptance Criteria and Reported Device Performance:

Study that proves the device meets the acceptance criteria:

• Sample Size: Not explicitly stated.
• Data Provenance: Not explicitly stated, but implies laboratory-based, prospective testing.
• Type of Ground Truth: The ground truth is the physical observation of the color change of the chemical indicator (magenta to yellow) after exposure to the V-PRO maX 2 Sterilizer Specialty cycle.

4. VERIFY VH2O2 Indicator Tape (K231488)

Acceptance Criteria and Reported Device Performance:

Study that proves the device meets the acceptance criteria:

• Sample Size: Not explicitly stated.
• Data Provenance: Not explicitly stated, but implies laboratory-based, prospective testing. The manufacturing facility is in Buena Park, CA (USA).
• Type of Ground Truth: The ground truth is the physical observation of the color change of the indicator tape (pink to peach, yellow or lighter) and its physical integrity (remaining adhered) after exposure to the V-PRO maX 2 Sterilizer Specialty cycle.

Summary of non-applicable AI/ML specific criteria:

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is based on physical/chemical reaction.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human adjudication of complex data; rather, direct observation of state change.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical chemical indicator, not an algorithm.
• The sample size for the training set: Not applicable. These are physical devices, not AI models requiring training data.
• How the ground truth for the training set was established: Not applicable for the same reason.

In all cases, the primary purpose of the testing described is to confirm that the chemical indicators reliably undergo the expected color change (and adhere, for the tape) when exposed to the specific V-PRO maX 2 Sterilizer Specialty cycle, thereby demonstrating their continued safety and effectiveness for an expanded indication.

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The Celerity™ HP Chemical Indicator is a vaporized hydrogen peroxide multivariable chemical indicator. It is designed for routine monitoring of the following cycles:

· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or

• Standard, Advanced, Express, Flex or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

The Celerity™ HP Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. If the critical variables are achieved, the color of the indicator ink changes from magenta to orange/yellow or lighter yellow when exposed to the V-PRO® Low Temperature Sterilization System cycles or ASP STERRAD® System cycles. The indicator is validated to function as a multiple variable indicator with increased resistance characteristics similar to ISO 11140-1:2014 end points for a Type 4 Vaporized Hydrogen Peroxide (VHP) Chemical Indicator (CI). No changes have been made to the device other than additional testing and updating the labeling for multivariable indicator claims.

The provided text describes the acceptance criteria and study results for the CELERITY HP Chemical Indicator, a medical device used to monitor sterilization cycles. Here's a breakdown of the information requested:

Acceptance Criteria and Device Performance

1. Table of acceptance criteria and the reported device performance:

Regarding the other information, the provided text does NOT contain details about the following aspects, which are typically relevant for AI/ML-based medical devices or studies involving human readers:

2. Sample size used for the test set and the data provenance: This information is not explicitly stated. The study refers to "All CI" for the multivariable performance, implying a batch of Chemical Indicators were tested. The provenance (country of origin, retrospective/prospective) is also not detailed, though the manufacturing facility is in the United Kingdom.

3. Number of experts used to establish the ground truth for the test set and their qualifications: This device is a chemical indicator that shows a color change, not an AI/ML system requiring expert interpretation of images. Therefore, expert consensus on ground truth in that context is not applicable. The "ground truth" here is the physical reaction of the chemical indicator to specific sterilization parameters as defined by ISO standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a chemical indicator.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical chemical indicator, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical chemical indicator.

7. The type of ground truth used: The ground truth for this device's performance is established by ISO 11140-1:2014 standards for chemical indicators and verified by subjecting the indicators to controlled sterilization conditions with specified time, temperature, and sterilant concentration. The "complete color change" and "incomplete color change" are the physical manifestations defining the ground truth.

8. The sample size for the training set: Not applicable. This is an engineered chemical product, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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The Celerity™ HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the:

· Lumen. Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or

· Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

The Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the:

· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or

· Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology.

The VERIFY V24 Self-Contained Biological Indicator Vial Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the:

· Lumen. Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or

• Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology.

The Celerity HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units through a visible change from magenta to orange/yellow or lighter, when the device has been exposed to the:

• . Lumen, Non-Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• . Standard. Advanced, Express, Flex or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

The Celerity "10 HP Chemical indicator is provided in three formats:

• Version 1: Celerity™ Chemical Indicator (CI) .
• . Version 2: Celerity™ Vaporized |VH2O2 Process Indicator Adhesive Label (PI)
• Version 3: VERIFY V24 Self-Contained Biological Indicator Vial Label (PI)

The three formats differ in their intended location inside the load to be sterilized. Version 1 is to be placed inside a pack to be sterilized. Version 2 is to be affixed to the outside of a pack by means of the adhesive back. Version 3 is to be affixed to the outside of a Self-Contained Biological Indicator by means of the adhesive back.

The proposed devices are manufactured by application of the indicator ink by printing onto a substrate in a variety of shapes in three constructions:

• Construction C Polypropylene ●
• Construction B - Spun-bonded polyolefin with an adhesive and a glassine backing paper
• Construction D - polypropylene with an adhesive and a glassine backing paper.

The proposed devices will consist of one of the above substrates with an indicator ink printed thereon.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• When exposed to VHP Resistometer cycles at the Pass condition (Test Point 1): Minimum 90% Celerity™ HP Chemical Indicator stripes must show a PASS result. | Pass |
  | Simulated Use Testing | Internal Method Used | - When exposed to V-PRO maX Non Lumen 1/84 cycles with ≥50 lb load (Fail condition): 100% Celerity™ HP Chemical Indicator stripes must show a FAIL result.
• When exposed to V-PRO and STERRAD cycles with the worst case loads: Minimum 90% Celerity™ HP Chemical Indicator stripes must show a PASS result. | Pass |
  | Fluorescent Light Stability Testing | Internal Method & ANSI/AAMI/ISO 11140-1:2014 | - Indicator start color to remain unchanged after exposure to fluorescent lighting for ≥ 30 days before processing.
• When exposed to VHP Resistometer cycles at the Fail parameters following exposure to fluorescent lighting for ≥ 30 days: 100% of Indicators tested must show a FAIL results (non-visible color change or color change to another color except orange/yellow).
• When exposed to VHP Resistometer cycles at the PASS parameters following exposure to fluorescent lighting for ≥ 30 days: Minimum 90% Indicators tested must show a PASS result (orange/yellow or lighter). | Pass |
  | Temperature Extremes Exposure (Freeze/Thaw) Testing | Internal Method & ANSI/AAMI/ISO 11140-1:2014 | - Indicator start color to remain unchanged after exposure to extreme temperatures before processing.
• When exposed to VHP Resistometer cycles at the Fail parameters following exposure to extreme temperatures: 100% of Indicators tested must show a FAIL results (non-visible color change or color change to another color except orange/yellow).
• When exposed to VHP Resistometer cycles at the PASS parameters following exposure to extreme temperatures: Minimum 90% Indicators tested must show a PASS result (orange/yellow or lighter). | Pass |
  | Transference Testing | ANSI/AAMI/ISO 11140-1:2014 | - Indicators placed between a piece of the same substrate and held together with tape, then processed in a double V-PRO maX 2 Lumen cycle (no load) and evaluated for off-set, bleed and migration. | Pass |
  | | | - Samples with reference and text ink processed in a double V-PRO maX 2 Lumen cycle (no load) and evaluated for smearing, discoloration and fading. | Pass |
  | Adhesion Stability (Vials) Testing | Internal Method Used | - When exposed to two consecutive V-PRO maX 2 Lumen cycles:
  • 0% samples show bleeding of the adhesive
  • 100% must be firmly affixed
  • 0% must show signs of peeling
  • Minimum 90% must show a PASS result | Pass |
  | Shelf Life Testing | ANSI/AAMI/ISO 11140-1:2014 | - After the process indicator has been aged: Minimum of 90% of indicators must PASS Type 1 PASS conditions.
• After the process indicator has been aged: 100% of indicators must FAIL. | Pass |
  | Post-Processing Stability Testing | Internal Method Used | - Indicator processed ink color remains unchanged for a minimum of 6 months following exposure to a PASS or FAIL cycle. | Pass |

2. Sample Size and Data Provenance for Test Set:

The document does not explicitly state the specific sample sizes (number of indicators) used for each individual test in the performance studies. However, for "Type 1 Performance Testing", "Simulated Use Testing", "Fluorescent Light Stability Testing", "Temperature Extremes Exposure Testing", "Shelf Life Testing", and "Adhesion Stability (Vials) Testing", the acceptance criteria mention percentages (e.g., "100% Celerity™ HP Chemical Indicator stripes", "Minimum 90% Celerity™ HP Chemical Indicator stripes"). This implies that multiple indicators were tested for each condition.

The data provenance is not explicitly stated in terms of country of origin. The manufacturing facility is in the United Kingdom, but the testing may have occurred elsewhere. The studies are described in the context of a 510(k) submission, which typically involves prospective testing designed to meet regulatory requirements.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

This information is not provided. The performance testing for these chemical indicators relies on objective color changes and adherence to established standards (ANSI/AAMI/ISO 11140-1:2014), rather than expert interpretation of the results. The 'ground truth' is the objective physical change of the chemical indicator based on exposure to sterilization conditions.

4. Adjudication Method for the Test Set:

Not applicable. The performance testing for chemical indicators is based on objective observable color changes and compliance with quantitative standards, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret images or other data, and the comparison is how AI assistance affects their diagnostic accuracy. Chemical indicators, like the Celerity™ HP, are designed for direct visual interpretation of a color change, not complex interpretation by multiple human readers.

6. Standalone (Algorithm Only) Performance Study:

Yes, the studies described are standalone performance studies of the chemical indicator itself. The device is a "Type 1 vaporized hydrogen peroxide sterilization process indicator" that provides a direct visual cue (color change) to indicate exposure to sterilization conditions. Its performance is evaluated based on its intrinsic ability to change color accurately under specific conditions, without human interpretation beyond basic color recognition.

7. Type of Ground Truth Used:

The ground truth used is primarily based on physical exposure to defined sterilization conditions (VHP Resistometer cycles at specific "Fail parameters" and "Pass condition", and various V-PRO and STERRAD cycles with worst-case loads). The observable color change (or lack thereof) in the chemical indicator is then compared against these known exposure conditions to determine if the indicator provides an accurate visual signal according to the standard.

8. Sample Size for Training Set:

Not applicable. Chemical indicators are passive devices that rely on a chemical reaction for their function, not on machine learning algorithms that require a "training set" of data.

9. How Ground Truth for Training Set was Established:

Not applicable, as there is no training set for this type of device.

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The Celerity™ HP Chemical Indicator (CI) is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the:
· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
· Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

A version of the Celerity™ HP Chemical Indicator (CI) may be utilized on the V24 Self-Contained Biological Indicator Vial Label and is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the:
· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology.

The Celerity™ HP Chemical Indicator (CI) is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the:

• . Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP ● STERRAD® System, including those systems with ALLClear Technology.

A version of the Celerity™ HP Chemical Indicator may be utilized on the V24 Self-Contained Biological Indicator Vial Label and is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the:

• Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle . of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP ● STERRAD® System, including those systems with ALLClear Technology

The CI is composed of the following components:

• Substrate ●
• Indicator Ink

The PI is composed of the following components

• Substrate
• Indicator Ink
• Adhesive ●
• Backing Paper

This document describes the Celerity™ HP Chemical Indicator (CI), a Type 1 vaporized hydrogen peroxide sterilization process indicator. The device is designed to distinguish between processed and unprocessed units through a visible color change from red to orange/yellow when exposed to specific sterilization cycles of V-PRO® Low Temperature Sterilization Systems and ASP® STERRAD® Systems.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). However, it implies that the testing was conducted by STERIS Corporation or its subsidiary Albert Browne Ltd., located in the United Kingdom. Given the nature of chemical indicator testing, it is likely that the testing involved multiple samples for each stress/condition investigated. The studies are non-clinical performance data, implying these were laboratory-based experiments.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to a chemical indicator device. The "ground truth" for chemical indicators is based on whether the indicator changes color in response to specific sterilization parameters (e.g., presence of hydrogen peroxide) and according to established international standards (ANSI/AAMI/ISO 11140-1:2014). This is a physical or chemical reaction, not a subjective interpretation requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The color change of a chemical indicator is a direct, observable outcome, not subject to human adjudication in the same way as, for example, image interpretation. The "adjudication" is essentially a pass/fail determination based on the observable color change as per the device's design and specified standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for devices that rely on human interpretation, such as imaging AI algorithms, to assess the impact of the device on reader performance. Chemical indicators do not involve human interpretation in this manner.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are standalone performance tests of the chemical indicator itself. The device is a "Type 1 process indicator," meaning it provides a visual confirmation of exposure to the sterilization process. Its function is entirely automated in terms of its chemical reaction to sterilization conditions; there is no "human-in-the-loop" performance aspect in the mechanism of the indicator itself. Its performance is assessed purely on its ability to change color accurately under specified conditions.

7. The Type of Ground Truth Used

The ground truth used for this chemical indicator's performance evaluation is based on controlled exposure to validated sterilization cycles and conformance to established international standards (ANSI/AAMI/ISO 11140-1:2014). The expected color change (red to orange/yellow) when exposed to these conditions, and the lack of change when not exposed, constitutes the ground truth.

8. The Sample Size for the Training Set

No training set is mentioned or applicable. Chemical indicators operate based on chemical reactions; they do not involve machine learning algorithms that require training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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